DEVICE: Tri-Wave Combination Stimulator (00860019001609)

Device Identifier (DI) Information

Tri-Wave Combination Stimulator
EMS100
Not in Commercial Distribution

ELITE MEDICAL SUPPLY OF NY
00860019001609
GS1
January 01, 2019
1
608469891 *Terms of Use
The Elite Medical Supply of NY EMS100 Tri-Wave Combination Stimulator (the Device) is a battery and 110V wall adapter powered electrotherapy devices intended for clinic and outpatient rehabilitative therapy, acute postoperative care and home use for patients suffering from a variety of chronic pain issues. Prescribed by a physician, it gives the clinician a variety of electrotherapy modes to treat a range of indications. The Device is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The Intended Use Environment is Home Healthcare but the Device can also be used in a Chiropractic, Physical Therapy or Pain Management Clinic. The Device uses a tactile button user interface for control of the operating system and therapy amplitude settings. The Device has a liquid crystal character display which provides information to the user and displays the current therapy settings. The Device’s therapeutic output is transmitted through the patient lead wires to the cutaneous hydrogel electrodes affixed to the user’s skin. The energy generated by the Device is conveyed, via the patient lead wires and cutaneous electrodes, through the patients skin to excite either the underlying motor nerves to elicit involuntary muscle contractions or the sensory nerves to manage pain.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46573 Physical therapy transcutaneous neuromuscular electrical stimulation system
An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.
Active false
36737 Interferential electrical stimulation system
An electrically-powered device assembly designed to stimulate peripheral nerves through the transcutaneous application of two currents of slightly different frequencies (e.g., 4000 and 4100 Hz) that cross-over/interfere, producing a beating frequency (i.e., difference between the frequencies of both stimuli) at the treatment point. It typically consists of an external pulse generator and a set of electrodes placed in position to produce the interference at the desired point. The system is used mainly to relieve/manage intractable pain; some include additional electrodes to provide other types of electrical stimuli or suction for therapeutic massage.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LIH Interferential Current Therapy
IPF Stimulator, Muscle, Powered
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

bcdac13c-4a6c-4195-b75e-5d9e95530741
October 24, 2024
8
March 16, 2018
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00860019001623 1 00860019001609 2019-01-01 Not in Commercial Distribution carrying case
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
716-712-0881
jnikiel@elitemedicalsupplyofny.com
CLOSE